MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT HBALC GEN. 3; ASSAY, GLYCOSYLATED HEMOGLOBIN

Model Number HBA1C TQ G3

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2023 a mechanism check was performed with acceptable results.The gear pump pressure, cell rinse tubing, and cell cover were all acceptable.It was noted that the sample probe rinse station had blood stains.Precision results and qc were acceptable."abnormal aspiration", "sample duplication" and "clot detection" errors were observed on the alarm trace data.The photometer lamp was last replaced on (b)(6) 2023.The sample probe was last replaced and adjusted on (b)(6) 2023.Cells were last replaced on (b)(6) 2023.The investigation did not identify a product problem.The investigation determined the event was consistent with sample quality issues or contamination of the sample probe.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for tina-quant hba1c gen.3 (hba1c) on a cobas 8000 c 502 module.The initial result from the c502 module was 7.89%.This result was reported outside of the laboratory where the doctor complained as the patient had an hba1c of 5.7% on an unspecified point-of-care instrument.On (b)(6) 2023 the sample was repeated on the c502 module with a result of 5.66%.The c502 module serial number was (b)(4).

• Brand Name: TINA-QUANT HBALC GEN. 3
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16460309
• MDR Text Key: 310440101
• Report Number: 1823260-2023-00622
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K102914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: HBA1C TQ G3
• Device Catalogue Number: 05336163190
• Device Lot Number: 695526
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male